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Completed

NCT Number: NCT04188184

Tranexamic Acid Versus Epinephrine During Exploratory Tympanotomy

Exploratory tympanotomy is surgical access to the middle ear, made for diagnosis and management of unexplained conductive hearing loss, performed under an oto-microscope across the external auditory canal after tympanic membrane elevation to explore the middle ear structures

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut university, Asyut, Egypt

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About this study

Epinephrine is a vasoconstrictor searched intensively for ptimization of the surgical field during microscopic ear and sinus surgeries with controversial results given the possible cardiovascular complication in case of systemic absorption,especially in vulnerable cardiac patients.Tranexamic acid (TXA) as an antifibrinolytic medication is used to treat or prevent excessive bleeding in significant trauma, surgery, tooth removal, or nasal bleeding, discovered by Japanese researchers. TXA, given either oral or intravenous, is a derivative of lysine amino acid; it acts reversibly on the lysine binding sites to block it on the plasminogen molecules. TXA consequently hinders the stimulation of plasminogen competitively, thus reduces its conversion into plasmin. Plasminogen is the enzyme that leads to the degradation of a fibrin clot, fibrinogen, and other plasma proteins, such as factors V and VIII. More than 95% of TXA intravenous administered dose eliminated unchanged through the urinary system. Twenty-four hours after intravenous administration of TXA has demonstrated accumulative excretion of approximately 90%, whereas only 3% is bound to plasminogen. TXA is minimally excreted in breast milk while it can freely cross the blood brain barrier and the placenta .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 - 60 years old
  • ASA (I and II)
  • Hb level > 10 mg/dl
  • elective ear exploratory tympanotomy surgery under general anesthesia.

Exclusion criteria

  • Allergy to TXA
  • bleeding/coagulation disorders
  • psychiatric illness
  • acute and chronic renal failure
  • heparin use within 48 hrs or aspirin use within seven days before surgery,
  • pregnancy
  • liver cirrhosis
  • color blindness
  • cardiac stent.

Treatment and study plan

Tranexamic Acid

Drug

received topical 1 gram of TXA diluted in 200 ml of normal saline (0.9%) for topical use to rinse the bleeding sites and soak the used gauze for local compression.

Epinephrine

Drug

received Epinephrine 1 mg diluted in 200 ml normal saline (0.9%) for topical use to rinse the bleeding sites and soak the used gauze for local compression.

Primary outcomes

  1. State of surgical field categorized by surgeons based on Boezaart classification

    Time frame: 2 hour

    Grade Description 0 No bleeding (cadaveric conditions)

    • Slight bleeding: no suctioning required
    • Slight bleeding: occasional suctioning required
    • Slight bleeding: frequent suctioning required, bleeding threatens surgical field a few seconds after suction is removed
    • Moderate bleeding: frequent suctioning required and bleeding threatens surgical field directly after suction is removed
    • Severe bleeding: constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible

Secondary outcomes

  1. bleeding volume

    Time frame: 2 hour

    The quantity of blood (ml) = (mass of used + fresh gauze - weight of all sponges before surgery) / 1.05.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Topical Use of Tranexamic Acid Versus Epinephrine to Optimize Surgical Field During Exploratory Tympanotomy

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 5, 2019
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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